Chronic TBI: A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01171131

Collaborator

(none)

Enrollment

Location

172

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Other: Blood/saliva sampling

Study Design

Study Type:

Observational

Actual Enrollment :

96 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

A Pilot Study to Identify Biomarkers Associated With Chronic TBI

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Chronic TBI Patients - Non-penetrating Chronic TBI patients should have a history of head trauma manifesting in one or more of the following: Loss of consciousness Post-traumatic amnesia Focal neurologic deficits, seizure Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).	Other: Blood/saliva sampling one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
Chronic TBI Patients - Blast Chronic TBI Blast injury patients should have a history of head trauma manifesting in one or more of the following: Loss of consciousness Post-traumatic amnesia Focal neurologic deficits, seizure Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).	Other: Blood/saliva sampling one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
Healthy Volunteers Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have, No significant medical history Take no medications (other than birth control pills) Fever free No history of head trauma or recent injury/infection No history of neurological or psychiatric disorders or alcohol or drug dependency.	Other: Blood/saliva sampling one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

Arm

Intervention/Treatment

Chronic TBI Patients - Non-penetrating

Chronic TBI patients should have a history of head trauma manifesting in one or more of the following: Loss of consciousness Post-traumatic amnesia Focal neurologic deficits, seizure Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Other: Blood/saliva sampling

one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

Chronic TBI Patients - Blast

Chronic TBI Blast injury patients should have a history of head trauma manifesting in one or more of the following: Loss of consciousness Post-traumatic amnesia Focal neurologic deficits, seizure Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Other: Blood/saliva sampling

one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

Healthy Volunteers

Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have, No significant medical history Take no medications (other than birth control pills) Fever free No history of head trauma or recent injury/infection No history of neurological or psychiatric disorders or alcohol or drug dependency.

Other: Blood/saliva sampling

one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)

Outcome Measures

Primary Outcome Measures

Proteomic analysis of plasma [average of 6 months post injury]
The aim is to identify biomarkers in the blood of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.

Secondary Outcome Measures

Proteomic analysis of saliva [average of 6 months post injury]
The aim is to identify biomarkers in the saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Chronic TBI patients:

Inclusion Criteria

Have a history of head trauma manifesting in one or more of the following:

Loss of consciousness
Post-traumatic amnesia
Focal neurologic deficits, seizure
Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.)

Exclusion Criteria

Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).

Healthy volunteers:

Inclusion Criteria

No significant medical history
Take no medications (other than birth control pills)
Fever free
No history of head trauma or recent injury/infection
No history of neurological or psychiatric disorders or alcohol or drug dependency.

Exclusion Criteria

Inability to provide informed consent
age/gender match not available in TBI cohort

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TIRR	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator: Georgene Hergenroeder, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgene Hergenroeder, Associate Professor, Neurosurgery, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT01171131

Other Study ID Numbers:

HSC-MS-09-0334

First Posted:

Jul 28, 2010

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Georgene Hergenroeder, Associate Professor, Neurosurgery, The University of Texas Health Science Center, Houston

TBI

Brain Injury

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Study Results

No Results Posted as of Sep 8, 2021